Ambu Cuff Pressure Gauge, Instructions For Use Manual, Page: 4 / 104

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Intended Use
The Cuff Pressure Gauge is used for inflation, deflation and pressure control of Tracheal Tubes with high
volume low pressure cuffs and Ambu® Aura Laryngeal Mask.
ATTENTION
• Read and follow the instructions for use carefully before using the product.
• The product must only be used by trained medical personnel.
• Before use, the products must be inspected visually for damages (cracks, breakage, etc.) and a func-
tional check must be performed (see section “Functional check”).
• The cuff pressure gauge is not suitable for MRI!
• In case that the cuff pressure gauge is used for monitoring and remains on the inflation line, the
pressure must be checked regularly every 15 minutes by the user. Pressure increase can be adjusted
by pressing the red release valve and pressure decrease can be adjusted by squeezing the inflation
bulb. This cuff pressure gauge is a manual system and can not hold the cuff pressure constantly over
a longer period.
• When disconnecting the cuff pressure gauge from the inflation line, it has to be disconnected
together with the connecting tubing as otherwise the system is open.
• A mechanical stop is integrated in the housing to prevent that the release valve gets stuck. The release
valve can get stuck by excessive strong activation. In this case, the device must not be used further
and must be returned to Ambu for repair.
• The connecting tube is for single use and must not be reprocessed. Reprocessing influences the func-
tion of the connecting tube. Any reuse involves the potential risk for cross contamination.
Functional Check
Test the Cuff Pressure Gauge as follows:
1a) Close Luer noozle with the finger.
1b) Inflate with the inflation bulb to 40 cmH
2
O; the value must be constant for 2 - 3 sec; in case of pres-
sure decrease, the device must be returned to Ambu for repair.
If a connecting tubing is used, the system consisting of Cuff Pressure Gauge and con-
necting tubing has to be checked as follows (additionally to 1):
2a) Attach the connecting tubing to the Luer nozzle of the Cuff Pressure Gauge.
2b) Seal the end of the connecting tubing with the finger.
2c) Inflate with the hand inflation bulb to 40 cmH
2
O; the value must be constant for 2 - 3 sec; in case of a
pressure decrease, the connecting tubing is leaking and must be replaced. Check again with the new
connecting tubing (repeat steps 2a - 2c).
During connection and disconnection of the connecting tube, do not bend the luer fitting of the
device, to prevent damage. Furthermore, make sure that the connecting tubing is held on the con-
nector (not at the tubing).